MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Inflammation (1932); Vomiting (2144); Hernia (2240)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Pc (b)(4).Health effect - clinical code = pocket erosion (e200601) attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Photographic evaluation per the ethicon medical safety officer: i reviewed 3 endoscopic images associated with this complaint.Two images were taken from the distal esophagus and showed a linx device that had eroded through into the lumen of the esophagus.The clasp was visible.The third image was a retroflexed view of the cardia which also showed the linx device in the lumen of the stomach.There was a guide wire and biopsy forceps also visible.The images are consistent with a device that had eroded into the esophagus.Additional information was requested, and the following was obtained: when did the vomiting of the blood occur (immediately post op or days later)? approximately 10 days postop.What was done about the vomiting blood? the patient was admitted to the hospital.Had an egd and was seen to have severe esophagitis.No erosion was noted.Started on ppi and carafate.Resumed diet.Esophagram and chest ct demonstrated recurrent hiatal hernia and migration of device onto the stomach.The plan was to wait 6-8 weeks and plan for reoperation to remove the device when maximal inflammation subsided.The patient was discharged after 72 hours able to tolerate po diet.He was relatively asymptomatic until pod 30 when he developed belching and dysphagia.Repeat egd demonstrated erosion of 2 beads.Chest ct and esophagram demonstrated no leak.The plan was to wait additional 2-3 weeks to allow the capsule to solidify and attempt endoscopic retrieval which has been reportedly accomplished.When did they first scope patient after surgery? upon presentation with hematemesis.How big was the hernia during the implant? large hernia with entire stomach in chest.8-10 cm.Was mesh used when repairing the hernia? no.Did they totally repair the hernia before the linx was implanted? yes.Has the patient had any dilations, egd, or other procedures between the linx implant and the discovery of the erosion? please describe and include the dates of the procedures.Readmitted for upper gi bleed, egd on 10/19/20 showed recurrent hiatal hernia with ulcerated mucosa and severe esophagitis.Egd (b)(6) 2020 with failed attempt to cut linx with ovesco remove the device how many beads eroded? initially, it appeared that about 4 beads eroded including the clasp.Where were the eroded beads positioned? 6cm onto the stomach (it slid down the recurrent paraesophageal hernia).Was the patient stented? no.What is the current condition of the patient? at home, doing well, the surgeon is seeing him in the office soon to discuss fixing his recurrent hernia.When did the vomiting of the blood occur (immediately post op or days later)? he was readmitted to the outside facility that initially performed his surgery on postop day 4 for bleeding.What was done about the vomiting blood? multiple scopes, transfusions, ppi, second opinion sought.Additional information was requested, and the following was obtained: in one email you said ¿when did the vomiting of the blood occur (immediately post op or days later)? approximately 10 days postop".In another email, you said below ¿when did the vomiting of the blood occur (immediately post op or days later)? he was readmitted to the outside facility that initially performed his surgery on postop day 4 for bleeding¿.Was it 10 or 4 days that the vomiting of the blood occurred? the 4 days answer was from the explanting surgeon who i believe received the information from the patient.The 10 days answer was from the implanting surgeon who initially saw the patient after vomiting occurred.To answer your question, i do not know who is correct as each have varying answers.Could we please obtain the operation notes if possible? using a double-channel therapeutic scope, a boston scientific 0.035" jagwire was threaded through the smaller channel of the scope and between the eroded portion of the linx device and the wall of the gastric lumen.A 20mm snare was then passed through the larger working channel, and threaded between the eroded linx device and the gastric lumen on the opposite side.The distal end of the jag wire was snared, and the gastroscope and both free ends of the jagwire were slowly pulled out of the patients mouth, avoiding undue tension on the linx device.The free ends of the jag wire were passed through a 14fr metal sheath and then through the cook medical soehendra lithotripsy device.The gastroscope and the metal sheath were advanced to the linx device, and the handle of the lithotripsy device was cranked until the linx was cut.This took three attempts, as the soft end of the jag wire kept breaking.A second jagwire through a 14fr metal sheath was passed into the stomach, and some time was spent trying to capture the free end of the linx device for further cutting.With both an antegrade view, as well as retroflexed view, a combination of hot biopsy forceps, 20mm snare, and rat-toothed forceps were ultimately trialed.During this process, the rat toothed grasper actually pulled the clasp end of the cut linx device intraluminally, and this 3 bead segment was left in the antrum for later removal.Additionally, a very small metallic disc shaped fragment was found in the esophageal lumen and was removed with forceps.One long intraluminal segment remained.With the double channel gastroscope in retroflexion, a 20mm snare was fed through the looped jag wire visualized extending from the metal sheath.The snare then encircled the remaining intraluminal linx device.The snared linx device was pulled through the looped jag wire.The handle of the cook soehendra lithotripsy device was then slowly cranked, until the remaining linx device was transected at the level of the mucosa.A small amount of traction was applied to the snare to fortunately pull the entirety of the remaining linx device into the gastric lumen.No full thickness perforation was appreciated.There was some inflammatory mucosal oozing during the procedure, but no active bright red bleeding was ever appreciated.The patient was examined, and no pneumoperitoneum or cervical crepitus was appreciated.A roth net was passed to retrieve the magnetic beads from the gastric antrum, was were removed from the patient and sent to pathology.A nasogastric tube was placed under endoscopic visualization for postoperative gastric decompression.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient was implanted with a lxmc17.The device was implant for gerd and a hiatal hernia.Soon after the patient woke up vomiting blood.The patient was admitted on (b)(6) 2020 and the surgeon found that the device had eroded into the patients esophagus.The surgeon attempted to remove the device but failed to do so.The patient was referred to another doctor.That doctor called the linx rep for more information regarding the explant and erosion.The surgeon was given tips on how to remove the device that had eroded.On (b)(6) 2020 the device was explanted endoscopically.

Manufacturer Narrative

(b)(4).Date sent: 02/02/2021 the dhr for lot 26522 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11178442
• MDR Text Key: 241251079
• Report Number: 3008766073-2021-00009
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 26522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention